Kornimate/medical-research-clean huggingface dataset:
upper airway collapse in patients with obstructive sleep apnea syndrome by drug induced sleep endoscopy

Conditions: Sleep Apnea Syndrome

Summary: this is a prospective, interventional cohort study of drug-induced sleep endoscopy (dise). the goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea hypopnea syndrome (osahs) diagnosed in a prior polysomnography. this study correlates the sedation level measured by entropy during dise using propofol via a tci pump with the local obstruction patterns of the upper airway according to the vote classification. as osahs is a widespread disease and the dise procedure has become a common tool for diagnosis and evaluation of further treatment, a growing number of research articles deal with this topic. these articles are available through pubmed.


Eligibility criteria:
inclusion criteria: * documented sleep apnea syndrome with an ahi \> 5 diagnosed by polysomnography exclusion criteria: * active infection * performed oral, head or neck surgery, pregnancy, * asa classification iii or higher, * chronic use of alcohol, sedatives or illicit drugs and chronic * obstructive pulmonary disease.
acute vascular response to meals varying in glycemic index and glycemic load

Conditions: Healthy

Summary: this study examines the effects of carbohydrate type (high- or low-glycemic index (gi)) and amount (high- or low-glycemic load (gl)) have on blood glucose levels, blood pressure and arterial stiffness in healthy individuals. it will also determine whether subjective ratings such as test meal palatability and hunger are related to changes in blood glucose. the investigators hypothesize that: (1) high-gi meals, regardless of gl, will increase arterial stiffness; low-gi meals, regardless of gl, will have a neutral or lowering effect on arterial stiffness (augmentation index). (2) high-gi meals, regardless of gl, will have an elevating effect on both central and peripheral blood pressures. (3) the incremental area under the curve for blood glucose will show most significant differences between high-gi, high-gl and low-gi, low-gl meals at 30 and 90 min.


Eligibility criteria:
inclusion criteria: * healthy * age 18 - 75 years * bmi 18 - 25 kg/m2 * brachial systolic blood pressure \< 140 mmhg * brachial diastolic blood pressure \< 90 mmhg exclusion criteria: * primary hypertension * diabetes * allergy or sensitivity to any foods to be used in the study * gastrointestinal disorders * chronic kidney disease * liver disease * hepatitis * estrogen-sensitive cancer * heavy alcohol use * sleep apnea * bleeding disorders * planned surgery (within time frame of study) * angina * congestive heart failure * coronary revascularization * peripheral vascular disease and/or coronary/cerebrovascular events within the previous 6 months * positive hiv diagnosis * prescription of anti-depressants, anti-hypertensives, anti-coagulant medications, diuretics, sympathomimetics, herbal therapies, vitamin or k supplementation, medication affecting no synthesis * chronic use or prescription of nsaids * women of childbearing potential must not be pregnant or breastfeeding

Keywords: healthy glycemic index glycemic load blood glucose arterial stiffness
study to evaluate effects of emixustat hydrochloride in subjects with proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: to evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor biomarkers associated with proliferative diabetic retinopathy (pdr) from baseline to week 12.

this is a multicenter, randomized, double-masked, placebo-controlled study to evaluate the effects of emixustat in subjects with pdr. subjects will be randomly assigned to either emixustat or placebo arms and treated once daily (qd) for 12 weeks. doses of emixustat will be doubled on a weekly basis until week 4 after which all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen. subjects in the placebo group will be mock-titrated on the same schedule as those in the emixustat arm.

Eligibility criteria:
inclusion criteria: * able and willing to provide written informed consent * documented diagnosis of type 1 or type 2 diabetes mellitus * meets specific ocular criteria for the study eye including but not limited to, the presence of pdr with or without diabetic macular edema in study eye for which treatment can be deferred for at least 4 weeks after day 1 visit * media clarity, pupillary dilation, and subject cooperation sufficient to obtain adequate assessments exclusion criteria: * any condition that would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease or glycemic control) * history of myocardial infarction or other acute cardiac event * history of chronic renal failure requiring dialysis or kidney transplant * prior participation in any clinical study of emixustat * treatment with any investigational study drug within 30 days of screening * known allergy to fluorescein sodium for injection in angiography * treatment with specific prohibited medications or therapy beginning 4 weeks prior to screening and throughout the duration of the study * history of systemic anti-vegf or pro-vegf treatment within 4 months prior to randomization * pre-specified laboratory abnormalities at screening * specific ocular characteristics in the study eye * male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 30 days following completion of the study * female subjects of childbearing potential who are not willing to practice a medically accepted method of birth control with their non-surgically sterile male sexual partner from screening through 30 days following completion of the study * female subjects who are pregnant or lactating
effects of isis 113715 on insulin sensitivity, glucose, and lipid metabolism and energy expenditure in type 2 diabetics

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to examine the effects of isis 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * male or female (post menopausal and/or surgically sterile) * aged 18 to 70 years * treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dl, hematocrit of \>/= 35% and hba1c levels of \>/= 7% and \</= 10.0% * subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dl, hematocrit of \>/= 35%, and hba1c levels of \>/= 6.5% and \</= 9.0% exclusion criteria: * greater than 3 severe hypoglycemic episodes within six months of screen * pregnant, breastfeeding, or intends to become pregnant * clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alt greater than 1.5 times the upper limit of normal * history of hepatitis b surface antigen, hepatitis c antibody, or hiv * complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy) * clinically significant and currently active diseases * clinically significant abnormalities in medical history, physical examination, or laboratory examination

Keywords: fasting plasma glucose hba1c metabolism
using the s100b protein for emergency headache management care (s100)

Conditions: Headache, Migraine; Hemorrhage

Summary: the purpose of this study is to determine the negative predictive value of protein s100b that could exclude subarachnoid and intracranial haemorrhage for patient that present severe headache within the last 3 hours.

this study will be proposed to every patient that correspond to eligibility criteria, such as presenting a severe headache (visual analog scale ≥ 6/10) within 3 hours before arriving to the emergency. after signing the informed consent, a blood sample will be taken in order to dosage s100b protein of each patient, and then they will have a brain scan. the trial ends after the brain scan for each patient. results of brain scans will be compared with results of s100b dosage.

Eligibility criteria:
inclusion criteria: * male or female over 18 years-old * patient presenting at the emergency service a non-traumatic severe headache lasting for less than 3 hours. the severity is defined as a vas ≥ 6/10 * blood sample can be taken within 1 hour following the emergency admission * vas \> 6 or glasgow \< 8 * signed and dated informed consent by patient, or trusted person, or family exclusion criteria: * patient presenting headache after head trauma * pregnant or breastfeeding women * patient with a pathology causing the elevation of ps100b's rate such as alzheimer's disease, creuzfeld-jacob's disease, multiple sclerosis, cerebral tumour, trisomy 21, melanoma (diabetes excluded) * patient covered by social security regimen or equivalent * patient under guardianship (legal protection) * patient deprived of liberty by court or administrative order * any condition that could influence ps100b's dosage results according to the physician.

Keywords: protein s100b negative predictive value headache intracranial hemorrhage
cisplatin with alimta or gemcitabine in long infusion for mesothelioma

Conditions: Mesothelioma

Summary: this is a randomised phase ii clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.

combination of pemetrexed and cisplatin is now considered the standard systemic treatment for mesothelioma. three arguments against such a position are: 1. pemetrexed in combination with cisplatin was registered for mesothelioma on the basis of superiority over cisplatin alone, a clearly suboptimal control arm; 2. several phase ii trials of gemcitabine in standard doses or as low-dose in long infusion in combination with cisplatin have shown at least comparable activity; 3. due to high cost, pemetrexed is not available to many patients in countries with limited health care resources. during the past five years, our research team in ljubljana conducted a phase ii trial of low-dose gemcitabine (250 mg/m2) in 6-hours infusion and cisplatin for patients with mesothelioma. in an unselected population of patients including those in poor performance status, elderly, patients with advanced extrathoracic disease and patients in progression after previous chemotherapy, the response rate was 54%, and median survival was 16.5 months. on the basis of this favourable experience and in search of cost-effective treatment for mesothelioma, we here propose a randomised phase ii clinical trial to compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion. the primary endpoints are response rate and time to progression; secondary endpoints are survival, toxicity and quality of life.

Eligibility criteria:
inclusion criteria: * histologically proven mesothelioma. while local histopathology exam is sufficient to register a patient for the trial, all biopsies will be subject to central review (please see section 5.3.) * no history of other malignancy; or in complete remission for \> 3 years if previously treated for other malignancy; * chemo-naive; * performance status ≥ 70% (karnofsky); or ecog 0 - 2 ; * no peripheral neuropathy grade 2 or more (common toxicity criteria - ctc, nci), unless mechanical in origin; * no vascular disease grade 2 or more (nci ctc ver.3); * hemoglobin \> 100 g/l; * neutrophils \> 2.0 g/l; * platelets \> 100 x 109 /l; * kidney function: creatinine within normal limits + ecc \> 60 ml/min; or ecc \> 100 ml/min; * liver function: bilirubin \< 1.25 x unl; ast/alt \< 2 x unl; * cardiac compensation; * no active infection or other serious concomitant disease; * women are not pregnant * patient's understanding of the disease and treatment and written informed consent. exclusion criteria: • significant medical co-morbidity
prediction of heart failure and cognitive decline in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Heart Failure; Cognitive Decline

Summary: type 2 diabetes is a risk factor of heart failure and cognitive decline. heart failure at its early stage is often silent. at present, primary prevention for heart failure is not available. our aim is to identify diabetic patients at risk of heart failure in order to develop personalized preventive strategies. type 2 diabetes is vascular and metabolic risk factor for cognitive decline though a direct lesional effect but also through an interaction with underlying neurodegenerative lesions. our aim is to identify diabetic patients at risk of cognitive decline in order to develop personalized preventive strategies


Eligibility criteria:
inclusion criteria: * adults * persons able to understand and object to the information provided. * type 2 diabetic patient free of heart failure ≥stade b * patient affiliated with a social security scheme. * patient agreeing to sign the informed consent form exclusion criteria: * patient with dementia * patient with at least one of the criteria for heart failure ≥stade b

Keywords: dementia stroke prevention
effects of class iii elastics on stability of orthopaedic class iii correction

Conditions: Class III Malocclusion; Underbite

Summary: the purpose of this study is to evaluate the effects of adding elastics to orthodontic retainers on the stability of class iii correction and whether it reduces the need for jaw surgery.

over the years many types of appliances have been recommended for retaining class iii correction in growing children such as intermaxillary splints, class iii activator, frankel 3, class iii twin block, continued use of face-mask and chin-cup. however, currently none of these are in routine use and there is no evidence on the long term effectiveness of any retention protocol for class iii correction. one of the most commonly used retainers following orthodontic treatment is clear plastic retainers. there are no studies that investigated whether using class iii elastics in combination with clear plastic retainers improves the stability of class iii correction and reduces the need for later jaw surgery.

Eligibility criteria:
inclusion criteria: * patients that completed their orthodontic treatment for the management of their skeletal class iii with upper jaw retrusion that was treated with class iii orthopaedic appliances, followed by full fixed appliances. * no congenital anomalies or craniofacial syndromes * no other orthodontic treatment * no medical history that effects growth exclusion criteria: * congenital anomalies or craniofacial syndromes * other orthodontic treatment * medical history that effects growth

Keywords: class iii malocclusion orthodontic retention
apatinib plus radiotherapy for patients with brain metastases from non-small-cell lung cancer

Conditions: Brain Metastases

Summary: to observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients


Eligibility criteria:
inclusion criteria: 1. aged 18 to 75 years old, males or females;. 2. according to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations; 3. subjects failed first-line standard chemotherapy ; 4. subjects expected survival of more than 3 months; 5. eastern cooperative oncology group performance status :0-2 points; 6. the main organ function is normal, that is to meet the following standards:(1) blood routine examination meets the following standards a. hemoglobin ≥90 g/l；b. absolute neutrophil count≥1.5×10\^9/l； c. platelet ≥80×10\^9/l； (2)blood biochemistry examination meets the following standards a.total bilirubin \<1.5 times the upper normal limit；b.glutamic transaminase \<2.5 times the upper normal limit, glutamic-oxalacetic transaminase \<2.5 times the upper normal limit， for patients with liver metastasis ,the glutamic transaminase and glutamic-oxalacetic transaminase index is less than 5 times the upper normal limit c.serum cr was less than 1.25 times the upper normal limit 7. women of reproductive age must undergo urine tests to eliminate the possibility of pregnancy.during the period of treatment and within 8 weeks after the treatment, the subjects voluntarily adopted appropriate methods of contraception . 8. subjects volunteered to participate in this study and signed informed consent exclusion criteria: 1. patients with meningeal metastasis; 2. patients with intracranial stroke; 3. previous toxicity associated with chemotherapy and / or radiotherapy persisted; 4. radiological evidence indicates the presence of an empty or necrotic tumor; 5. radiological evidence indicates the presence of a central tumor invading large blood vessels; 6. patients need to be treated with anticoagulants or antiplatelet drugs; 7. the subjects with abnormal coagulation function and bleeding tendency (inr\>1.5×uln、aptt\>1.5×uln);during the past 6 months, the subjects experienced severe thrombosis or clinically related severe bleeding events;in the past 3 months, clinically significant hemoptysis occurred;the subjects had inherited bleeding or thrombosis tendency; 8. subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs; 9. other investigators believe that patients are not eligible for inclusion

Keywords: brain metastases
pharmacokinetics of insulin detemir in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to evaluate the the dose-response of insulin detemir and insulin nph in subjects with type 2 diabetes of various race and ethnicity.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (oads) * duration of diabetes at least 12 months * body mass index (bmi) below 33 kg/m\^2 * hba1c maximum 10 % based on analysis from the central laboratory exclusion criteria: * current treatment with insulin above 1.2 u/kg/day * current treatment with drugs known to interfere with glucose metabolism other than oads such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (mao) inhibitors * blood donation of more than 500 ml within the last three months
guanfacine in children with tic disorders

Conditions: Tourette Disorder; Tourette Syndrome

Summary: the goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name intuniv) in children with tourette disorder (td, also called tourette syndrome).

guanfacine is commonly used for the treatment of tics in children with tourette disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. this pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with td. rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. immediate-release guanfacine is frequently used in children with td, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. the use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings. this is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with intuniv.

Eligibility criteria:
inclusion criteria: * diagnosis of tourette disorder or chronic motor or vocal tic disorder. * between ages 6 yrs 0 mos and 17 years 0 months. * weight \>/= 15 kg (33 lbs). * ability to swallow pills whole. exclusion criteria: * iq \< 80. * positive pregnancy test. * positive drug test. * low blood pressure. * prior history of hypersensitivity to guanfacine. * prior failed treatment with an adequate trial of guanfacine in last 2 years. * concurrent treatment with another psychoactive medication for tics, stimulant medication, or habit reversal therapy. * medication for ocd, anxiety or depression will be allowed if dose is stable for 8 wks with no planned changes; ssris are allowed.

Keywords: tourette syndrome tourette disorder tics motor tics vocal tics intuniv guanfacine medication drug placebo child children adolescent
study of bh4, a new and simple treatment of mild pku

Conditions: Phenylketonuria

Summary: the main purpose is to test whether treatment with bh4-tablets can replace the protein restrictive diet in patients with mild pku caused by a certain frequent mutation.

pku, phenylketonuria, is a rare, inherited metabolic disorder that results in mental retardation if not a very strict low-protein diet is started within the first weeks of life. the conversion of phenylalanine, phe, to tyrosine is defect, phe accumulates, leading to brain damage. there are different degrees of severity, reflecting the spectrum of mutant genes. bh4, tetrahydrobiopterin, is a co-enzym for the conversion of phe to tyrosine. it is known that bh4 can lower phe in some patients with milder forms of pku. the main purpose is to test whether treatment with oral bh4 can replace the protein restrictive diet in patients with mild pku caused by the frequent mutation y414c in the phenylalanine hydroxylase gene.

Eligibility criteria:
inclusion criteria: diagnosed mild pku with 2 known mutations in the pah gene, hereof at least one y414c from the age of eight informed consent - exclusion criteria: less than 8 years of age pregnancy or treated with the intensive diet of pregnancy -

Keywords: mild pku y414c 5,6,7,8-tetrahydrobiopterin, bh4 treatment without protein restriction